Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086399
Company: MEDICIS
Company: MEDICIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOLAIR | THEOPHYLLINE | 125MG | TABLET;ORAL | Discontinued | None | No | No |
THEOLAIR | THEOPHYLLINE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/30/1980 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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01/20/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/08/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/18/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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06/22/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |